PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1

PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 is an FDA 510(k)-cleared medical device (K083677) manufactured by Commwell , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 9, 2009. Regulation: 8.